JP6804931B2 - Anti-adhesion membrane for medical devices and medical devices - Google Patents

Description

The present invention relates to an adhesion-preventing film for medical devices and medical devices.

An anti-adhesion film may be coated on the surface of the medical device in order to prevent biological substances and the like from adhering to the surface of the medical device. However, for example, in a medical device that emits high-frequency power to a biological substance, the biological substance firmly adheres to the surface of the medical device due to denaturation of a protein component or the like of the biological substance at a high temperature. Therefore, in medical instruments that emit high-frequency power to biological substances, it is strongly required to further improve the adhesion prevention performance.
For example, in the technical field of a cutting tool for cutting an adhesive object to be cut such as an adhesive tape, as described in Patent Document 1, a silica continuous coating layer is used as a first layer, and a silica particle discontinuous layer is used as a second layer. An adhesion prevention film using a silicone layer as the third layer is known.

Japanese Unexamined Patent Publication No. 2013-018112

However, the above-mentioned prior art has the following problems.
Since the adhesion prevention film described in Patent Document 1 does not have conductivity, it is not a technique that can be adopted for medical devices that require conductivity, such as high-frequency treatment tools.
As a technique for imparting conductivity to an adhesion prevention film, an adhesion prevention film for probe pins for energizing an integrated circuit chip of a semiconductor wafer is known.

The present invention has been made in view of the above problems, adhesion medical device capable of improving adhesion prevention performance BIOLOGICAL materials using high-frequency power to be that physicians療機device releasing the biological material An object of the present invention is to provide a medical device that emits high-frequency power to a biological substance capable of improving the adhesion prevention performance of the preventive film and the biological substance.

In order to solve the above problems, the anti-adhesion film for medical devices according to the first aspect of the present invention is a single-layer or multi-layer anti-adhesion film formed on the surface of a medical device that emits high-frequency power to a biological substance. A resin having a continuous use temperature of 200 ° C. or higher and an outermost layer having a plurality of conductive particles are provided, and a part of the plurality of conductive particles is exposed from the resin on the surface of the outermost layer. The plurality of conductive particles are formed with irregularities, and the plurality of conductive particles include a first conductive particle group having a median diameter of 1 μm or more and 20 μm or less, and a second conductive particle group having a median diameter of 0.01 μm or more and 0.5 μm or less. Includes a group of sex particles .
Here, the continuous use temperature of 200 ° C. means that the thermal deformation temperature of the resin composition conforming to ISO-75 under a load of 0.45 MPa is 200 ° C. or higher.

The adhesion-preventing film for medical devices is a single-layer or multi-layer adhesion-preventing film formed on the surface of a medical device, and is the outermost layer having a resin having a continuous use temperature of 200 ° C. or higher and a plurality of conductive particles. The outermost layer may have irregularities formed on the surface of the outermost layer by exposing a part of the plurality of conductive particles from the resin.

In the adhesion prevention film for medical devices, the resin having a continuous use temperature of 200 ° C. or higher is a silicone resin, a furan resin, a polyamide resin, an allyl resin, a polyimide resin, a PEEK (polyetheretherketone) resin, an epoxy resin, or more. It may contain one or more selected resins from the group consisting of.

In the adhesion prevention film for medical devices, the resin having a continuous use temperature of 200 ° C. or higher may be a silicone resin.

In the adhesion prevention film for medical devices, the size of the unevenness on the surface of the outermost layer may be 0.3 μm or more at the maximum height Rz.

In the adhesion prevention film for medical devices, the first conductive particle group includes composite particles having a particulate base material made of a non-conductor and a metal layer laminated on the surface of the base material. It may be.

In the adhesion prevention film for medical devices, the plurality of conductive particles may include composite particles having a particulate base material made of a non-conductor and a metal layer laminated on the surface of the base material. ..

In the anti-adhesion film for medical devices, the plurality of conductive particles may contain one or more metals selected from the group consisting of silver, platinum, copper, nickel, and gold.

In the adhesion prevention film for medical devices, a lowermost layer containing silica as a main component and in close contact with the surface of the medical device may be provided on the lower layer side of the outermost layer.

The medical device according to the second aspect of the present invention is a medical device that emits high-frequency power to a biological substance, and includes the above-mentioned adhesion prevention film for medical devices.

According to antiadhesive film medical device of the present invention, an effect that it is possible to improve the adhesion prevention performance BIOLOGICAL materials using high-frequency power to be that physicians療機device releasing the biological material.
According to the medical device that emits high-frequency power to the biological material of the present invention, there is an effect that the adhesion prevention performance of the biological material can be improved.

It is a schematic cross-sectional view which shows the structural example of the adhesion prevention film for medical devices of 1st Embodiment of this invention. It is a schematic cross-sectional view which shows the structural example of the adhesion prevention film for medical devices of the 2nd Embodiment of this invention. It is a schematic cross-sectional view which shows the structural example of the adhesion prevention film for medical devices of the 3rd Embodiment of this invention. It is a schematic block diagram which shows an example of the medical device of 4th Embodiment of this invention. It is sectional drawing of AA in FIG.

Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In all the drawings, even if the embodiments are different, the same or corresponding members are designated by the same reference numerals, and common description will be omitted.

[First Embodiment]
The adhesion prevention film for medical devices according to the first embodiment of the present invention will be described.
FIG. 1 is a schematic cross-sectional view showing a configuration example of an adhesion prevention film for a medical device according to the first embodiment of the present invention.
Since each drawing is a schematic drawing, the shape and dimensions are exaggerated (the same applies to the following drawings).

FIG. 1 is a cross-sectional view illustrating a structure near the surface of a grip portion that grips a living body in a medical device. This grip portion is configured to apply high frequency to the gripped living body, and is a non-insulating (conductive) adhesion prevention film 2 (for medical equipment) on the surface portion 1 of the medical device near the surface of the grip portion of the medical device. Adhesion prevention film, outermost layer) is formed.
The adhesion prevention film 2 of the present embodiment that constitutes the non-insulating portion of the medical device will be described.
In the present embodiment, the non-insulating portion of the medical device is composed of a single-layer adhesion prevention film 2.
The adhesion prevention film 2 is laminated on the surface 1a of the medical device surface portion 1. In the following, if there is no risk of misunderstanding, the surface 1a is the downward direction and the surface 2a (the surface of the outermost layer) opposite to the surface 1a is the upward direction in the film thickness direction of the adhesion prevention film 2. , Lower side, lower part, upper side, upper part, etc.
Since FIG. 1 is an enlarged view, the appearance of the adhesion prevention film 2 being formed on the entire surface 1a is drawn, but the portion where the adhesion prevention film 2 is formed may be only the portion where the non-insulating portion is formed. ..
The shape of the surface 1a is not particularly limited as long as the adhesion prevention film 2 can adhere to it. For example, the surface 1a may be a flat surface or a curved surface. In order for the adhesion prevention film 2 to adhere more firmly to the surface 1a, the surface 1a may be a rough surface.
Here, the rough surface means a surface on which an uneven shape such as 0.1 μm or more and 2.0 μm or less is formed in the arithmetic mean roughness Ra by a laser microscope. Such a rough surface can be formed, for example, by performing a roughing process using a blast treatment.

The adhesion prevention film 2 includes silicone 4 as a base resin, a plurality of first conductive particles 5A (first conductive particle group) which are a group of conductive particles dispersed in the silicone 4, and a plurality of second conductive particles. It is composed of conductive particles 5B (second conductive particle group).

The silicone 4 adheres to the surface 1a of the surface portion 1 of the medical device and holds the first conductive particles 5A and the second conductive particles 5B. The type of silicone resin forming the silicone 4 is not particularly limited as long as the continuous use temperature is 200 ° C. or higher. The continuous use temperature of 200 ° C. means that the thermal deformation temperature of the resin composition conforming to ISO-75 under a load of 0.45 MPa is 200 ° C. or higher.
As the silicone resin, for example, silicone resin SILRES (registered trademark) series for electronics (trade name; manufactured by Asahi Kasei Wacker Silicone Co., Ltd.) may be used.

Since the adhesion prevention film 2 uses a silicone resin having high heat resistance as the base resin, particularly good performance can be obtained as an adhesion prevention film for medical devices to which a high frequency is applied from a non-insulating portion. However, the base resin used for the adhesion prevention film 2 is not limited to the silicone resin as long as it has high heat resistance.
For example, as the base resin in the adhesion prevention film 2, various resins having a continuous use temperature of 200 ° C. or higher may be used. The type of the base resin may be, for example, a resin containing one or more resins selected from the group consisting of silicone resin, furan resin, polyamide resin, allyl resin, polyimide resin, PEEK resin, and epoxy resin.

The plurality of first conductive particles 5A and the plurality of second conductive particles 5B impart conductivity to the adhesion prevention film 2 and are exposed to the outside from the surface 4a of the silicone 4, so that the adhesion prevention film 2 is exposed. A concave-convex shape is formed on the surface 2a of the surface.
However, the median diameter of the first conductive particle group and the median diameter of the second conductive particle group are different from each other. In the present embodiment, the median diameter of the first conductive particle group is larger than the median diameter of the second conductive particle group.
When the median diameter of the first conductive particle group is larger than the median diameter of the second conductive particle group, the second conductive particle 5B easily enters the gap between the first conductive particles 5A. .. Therefore, the second conductive particles 5B that have entered the gap between the adjacent first conductive particles 5A or between the first conductive particles 5A and the surface 1a are the first conductive particles 5A or the surface. Contact with 1a increases the contact area and the conductive path. Therefore, the conductive performance of the first conductive particles 5A and the second conductive particles 5B in the adhesion prevention film 2 and the surface 1a is improved, and the volume resistivity is lowered.
Further, when the second conductive particles 5B enter the gap between the adjacent first conductive particles 5A or between the first conductive particles 5A and the surface 1a, the first conductive particles 5A Is firmly supported, so that the stability of the position of the first conductive particle 5A is improved.

For example, the median diameter of the first conductive particle group may be 1 μm or more and 20 μm or less. For example, the median diameter of the second conductive particle group may be 0.01 μm or more and 0.5 μm or less.
Here, the median diameter means the 50% particle diameter (D50) in the volume-based cumulative particle size distribution.
As a means for measuring the particle size distribution, a light scattering type particle size analyzer is used. Specifically, for example, a microtrack particle size analyzer based on a laser diffraction / scattering type, a nanotrack particle size analyzer based on a dynamic light scattering type, or the like is appropriately used according to the distribution range of the particle size of the measurement target.

The materials of the first conductive particles 5A and the second conductive particles 5B are not particularly limited as long as they are biocompatible and can obtain the conductivity required for the non-insulated portion. The first conductive particles 5A and the second conductive particles 5B may be metal particles or particles having a metal coating on the surface of non-conductive particles.
The metals used for the first conductive particles 5A and the second conductive particles 5B may be the same metal or different metals.
Examples of the metal material that can be used for the first conductive particles 5A and the second conductive particles 5B include silver, platinum, copper, nickel, and gold.
In the present embodiment, gold particles, which are particularly preferable in terms of biocompatibility and electrical conductivity, are used as the first conductive particles 5A and the second conductive particles 5B.

The blending amount of the first conductive particles 5A and the second conductive particles 5B in the adhesion prevention film 2 satisfies the impedance required for the non-insulated portion of the medical device, and the cut or sealed biological material is peeled off. Appropriate values that facilitate it may be adopted.
For example, when the number of the first conductive particles 5A increases, the uneven shape on the surface 2a is dominated by the amount of protrusion of the first conductive particles 5A, so that the unevenness becomes large. Therefore, the adhesion of the biological substance is lowered, and the biological substance is easily peeled off. On the other hand, since the second conductive particles 5B are relatively reduced, the second conductive particles 5B interposed between the first conductive particles 5A and between the first conductive particles 5A and the surface 1a are also present. It is reduced and the conductivity is reduced.
On the contrary, when the number of the second conductive particles 5B is relatively large, the conductivity is improved by the second conductive particles 5B, but the uneven shape of the surface 2a depends on the amount of protrusion of the second conductive particles 5B. Since it is dominated, the unevenness becomes smaller and it approaches a smooth flat surface. Therefore, the adhesion of the biological substance is increased and the biological substance is less likely to be peeled off.
The peeling performance due to such an uneven shape is determined by the size of the maximum height Rz of the uneven shape.
For example, the size of the unevenness of the surface 2a may be 0.3 μm or more at the maximum height Rz.

In order to form the adhesion prevention film 2 having such a structure, first, the silicone resin to be the silicone 4, the solvent for dissolving the silicone resin, the first conductive particles 5A, and the second conductive particles 5B are mixed. , Prepare a paint for forming the adhesion prevention film 2. Next, this paint is applied to the surface 1a of the surface portion 1 of the medical device.
The coating film method is not particularly limited, and an appropriate coating film method is used depending on the shape of the surface portion 1 of the medical device and the like. For example, examples of the coating film method include spin coating, screen printing, inkjet method, flexographic printing, spray coating film, gravure printing, hot stamping, dip coating and the like.
However, if necessary, the surface 1a may be roughened by roughening the surface 1a before the coating film is applied.
After the coating film, the coating film layer is heat-dried. As a result, the solvent volatilizes, the silicone resin solidifies, the layer thickness decreases, and a layer film of silicone 4 is formed. As a result, a part of the upper first conductive particles 5A and the second conductive particles 5B is exposed to the outside from the surface 4a. Further, the first conductive particles 5A and the second conductive particles 5B facing the surface 1a come into contact with the surface 1a.
With the above, the adhesion prevention film 2 is manufactured.

As shown in FIG. 1, the adhesion prevention film 2 of the present embodiment is fixed on the surface 1a by the silicone 4 being in close contact with the surface 1a of the medical device surface portion 1.
Inside the adhesion prevention film 2, many first conductive particles 5A and second conductive particles 5B are dispersed in the silicone 4 in a state of being in contact with each other. The first conductive particles 5A and the second conductive particles 5B are held by the solidified silicone 4 and their relative positions are fixed to each other.
At the boundary between the surface 1a and the adhesion prevention film 2, the first conductive particles 5A and the second conductive particles 5B facing the surface 1a are in contact with the surface 1a.
A part of the first conductive particles 5A and the second conductive particles 5B is exposed from the surface 4a of the silicone 4. Therefore, the surface 2a of the adhesion prevention film 2 is formed with an uneven shape formed by the first conductive particles 5A and the second conductive particles 5B.

With such a configuration, the surface portion 1 of the medical device and the first conductive particles 5A and the second conductive particles 5B on the surface of the adhesion prevention film 2 are conductive, and the adhesion prevention film 2 as a whole is conductive. Has sex.

In a medical device using such an adhesion prevention film 2 for a non-insulating portion, when high-frequency power is emitted from the non-insulating portion, a biological substance formed by denatured biological tissue in contact with the non-insulating portion adheres to the medical device. Cheap.
However, on the surface of the adhesion prevention film 2 of the present embodiment, the adhesion prevention film 2 having an uneven shape formed by gold particles is formed. Therefore, the adhesive force of the biological substance is lower than that in the case where it adheres uniformly to the entire surface such as a smooth surface. Therefore, even if a biological substance adheres, it is easily peeled off by a small external force.

As described above, according to the adhesion prevention film 2 of the present embodiment, the first conductive particles 5A and the second conductive particles 5B are exposed on the surface 2a to form irregularities, so that the biological material is formed. Even if it is used in a medical device that emits high-frequency power, it is possible to improve the performance of preventing the adhesion of biological substances.

[Second Embodiment]
Next, the adhesion prevention film for medical devices according to the second embodiment of the present invention will be described.
FIG. 2 is a schematic cross-sectional view showing a configuration example of an adhesion prevention film for a medical device according to a second embodiment of the present invention.

As shown in the cross-sectional structure in FIG. 2, the non-insulating portion of the medical device is replaced with the adhesion-preventing film 7 (adhesion-preventing film for medical devices) which is a multilayer film, instead of the adhesion-preventing film 2 in the first embodiment. Be prepared.
The adhesion prevention film 7 includes a first layer 6 (bottom layer) laminated on the surface 1a of the surface portion 1 of the medical device, and a second layer 3 (outermost layer) laminated on the upper surface 6a of the first layer 6. It is composed of two layers.
The first layer 6 is provided to improve the adhesion of the adhesion prevention film 7 to the surface 1a.
As the material of the first layer 6, an appropriate material having excellent adhesion to the second layer 3 and the surface 1a is used. In the present embodiment, since the base resin of the second layer 3 described later is made of a silicone resin, a silica layer containing silica as a main component is adopted as the first layer 6. To form the silica layer, for example, a coating agent such as Olam (registered trademark) glass coating series (trade name; manufactured by Artbreed Co., Ltd.) may be used.
The layer thickness of the first layer 6 can be an appropriate layer thickness as needed, such as adhesion strength and durability. For example, the layer thickness of the first layer 6 may be 0.1 μm or more and 10 μm or less.

In the present embodiment, the second layer 3 is configured in the same manner as the adhesion prevention film 2 of the first embodiment. Therefore, the base resin of the second layer 3 in this embodiment is silicone 4.
However, as in the first embodiment, the base resin of the second layer 3 may be replaced with a resin having a continuous use temperature of 200 ° C. or higher.

In order to form the adhesion prevention film 7 having such a structure, the first layer 6 is formed on the surface 1a of the surface portion 1 of the medical device, and then the second layer 3 is formed.
In order to form the first layer 6, for example, a coating liquid containing silica in a solvent is coated on the surface 1a of the surface portion 1 of the medical device, and then heat-dried.
Similar to the first embodiment, when the surface 1a is roughened, the thickness of the first layer 6 is made sufficiently thinner than the unevenness of the roughening, so that the first layer 6 is formed. An uneven shape can also be formed on the upper surface 6a.
The second layer 3 can be formed in the same manner as the adhesion prevention film 2 of the first embodiment, except that the second layer 3 is formed on the first layer 6.

According to the adhesion prevention film 7 of the present embodiment, as the outermost layer, a second layer 3 similar to the adhesion prevention film 2 of the first embodiment is provided, so that the biological material can be used as in the first embodiment. Even when used in medical devices that emit high-frequency power, the ability to prevent the adhesion of biological substances can be improved.
Further, according to the adhesion prevention film 7, the first layer 6 is formed between the second layer 3 and the surface 1a of the medical device surface portion 1. Since the first layer 6 is made of a silica layer, the adhesion to the surface portion 1 of the metal medical device is good, and the silicone 4 of the second layer 3, the first conductive particles 5A and the second conductive particles 3 are formed. Adhesion with the sex particles 5B is also good.
Therefore, the adhesion strength of the second layer 3 can be improved as compared with the case where the second layer 3 is formed directly on the surface 1a. Therefore, the durability and reliability of the medical device can be further improved.

[Third Embodiment]
Next, the adhesion prevention film for medical devices according to the third embodiment of the present invention will be described.
FIG. 3 is a schematic cross-sectional view showing a configuration example of an adhesion prevention film for a medical device according to a third embodiment of the present invention.

The adhesion prevention film 12 (adhesion prevention film for medical devices) of the present embodiment includes first conductive particles 15A in place of the first conductive particles 5A in the adhesion prevention film 2 of the first embodiment. .. The whole of the first conductive particles 15A constitutes the first conductive particle group. The median diameter of the first conductive particle group in the present embodiment is the same as that in the first embodiment.
Hereinafter, the points different from the first embodiment will be mainly described.

The first conductive particle 15A is a composite particle having a particulate base material 15a made of a non-conductor and a metal layer 15b laminated on the surface of the base material 15a.
The material of the base material 15a is not limited as long as it is a non-conductor. It is more preferable that the material of the base material 15a has good heat insulating properties. The base material 15a may have a hollow structure. The hollow structure may be a spherical shell structure or a porous structure. When the base material 15a has a hollow structure, the heat insulating property of the first conductive particles 15A can be improved as compared with the case where the base material 15a is a medium substance.
As the material of the base material 15a, for example, glass, silica, alumina, zirconia and the like can be used. As the base material 15a, hollow silica particles, hollow glass spheres, or the like may be used. Specific examples of the hollow glass sphere include 3M (registered trademark) Glass Bubbles (trade name; manufactured by 3M) and the like.
The content of the first conductive particles 15A in the adhesion prevention film 12 is such that the size of the unevenness of the surface 2a is 0.3 μm or more at the maximum height Rz, as in the first embodiment. There may be.

Examples of the metal material used for the metal layer 15b include silver, platinum, copper, nickel, gold, and the like, as in the case of the first conductive particles 5A in the first embodiment. The metal material used for the metal layer 15b may be the same as or different from the metal material used for the second conductive particles 5B.

The layer thickness of the metal layer 15b is not particularly limited as long as the required conductivity and durability of the adhesion prevention film 12 can be ensured. For example, since the specific surface area of a sphere is inversely proportional to the size of the diameter, the layer thickness of the metal layer 15b is thin when the particle size of the base material 15a is small, and the metal layer is thin when the particle size of the base material 15a is large. The layer thickness of 15b may be increased.
The metal layer 15b may be laminated on the base material 15a by an appropriate coating. As a coating method that can be used for forming the metal layer 15b, for example, methods such as electroless plating, PVD (Physical Vapor Deposition), and CVD (Chemical Vapor Deposition) can be applied. Examples of PVD include, for example, sputtering, vapor deposition and the like.

The adhesion prevention film 12 having such a structure is formed on the surface portion 1 of the medical device in the same manner as the adhesion prevention film 2 in the first embodiment.

The adhesion prevention film 12 has the adhesion of the first embodiment except that the first conductive particles 15A are used instead of the first conductive particles 5A of the adhesion prevention film 2 of the first embodiment. It is configured in the same manner as the preventive film 2. Therefore, as in the first embodiment, the anti-adhesion performance of the biological material can be improved even when used in a medical device that emits high-frequency power to the biological material.
Since the metal layer 15b is laminated on the surface of the base material 15a, the first conductive particles 15A in the present embodiment use a metal as compared with the first conductive particles 5A in the first embodiment. The amount is reduced. The non-conductor used for the base material 15a is cheaper than the metal material. When the diameter of the first conductive particle 15A is the same as that of the first conductive particle 5A, the amount of expensive metal material used is reduced, so that the component cost of the first conductive particle 15A is reduced. .. In particular, when an expensive material such as gold or platinum is used as the base material 15a, the effect of reducing the component cost becomes large.

Further, in the present embodiment, since the first conductive particle 15A is made of a composite of a metal material and a non-conductive material, the thermal conductivity is lowered. Therefore, since the first conductive particles 15A are contained in the adhesion prevention film 12, the heat insulating property of the adhesion prevention film 12 is improved.
For example, when the adhesion prevention film 12 is used on the surface of an electrode portion of a medical device that emits high-frequency power to a biological tissue (biological substance), the electrode portion becomes hot due to Joule heat caused by the high-frequency power. When the temperature of the electrode portion itself becomes high, the biological tissue in contact with the surface of the electrode portion is excessively denatured, and the biological tissue may easily adhere to the electrode portion.
However, in the present embodiment, by containing the first conductive particles 15A on the surface of the medical device in contact with the living body, an adhesion prevention film 12 having higher heat insulating properties than when only the metal particles are contained is formed. Has been done. Therefore, the good heat insulating performance of the adhesion prevention film 12 can prevent the living tissue from being excessively denatured. As a result, the adhesion prevention performance of the adhesion prevention film 12 is further improved.

[Fourth Embodiment]
Next, the medical device of the fourth embodiment of the present invention will be described.
FIG. 4 is a schematic configuration diagram showing an example of a medical device according to a fourth embodiment of the present invention. FIG. 5 is a cross-sectional view taken along the line AA in FIG.

The high-frequency knife 100 of the present embodiment shown in FIG. 4 is an example of the medical device of the present embodiment. The high-frequency knife 100 is a medical treatment tool that incises and excises a living tissue (biological substance), coagulates (hemostatic) the living tissue, and cauterizes the living tissue by applying a high-frequency voltage.
The high-frequency knife 100 includes a rod-shaped grip portion 102 for the operator to hold by hand, and an electrode portion 101 protruding from the tip of the grip portion 102.

The electrode portion 101 is brought into contact with the biological tissue to be treated and a high frequency voltage is applied. As shown in FIG. 5, the electrode portion 101 includes a metal electrode body 101A and an adhesion prevention film 101B (adhesion prevention film for medical devices).

As shown in FIG. 4, the outer shape of the electrode body 101A is a rectangular piece having rounded corners at the tip in the protruding direction. As shown in FIG. 5, in the cross section orthogonal to the protruding direction, the electrode body 101A has a flat shape in which the thickness decreases toward the outer edge. Although not particularly shown, the cross-sectional shape at the tip in the protruding direction also becomes thinner toward the outer edge.
As shown in FIG. 4, the electrode body 101A is electrically connected to the high frequency power supply 103 by the wiring connected to the base end portion held by the grip portion 102. A counter electrode 106 to be attached to the object to be treated is electrically connected to the high frequency power supply 103.

As shown in FIG. 5, the adhesion prevention film 101B is a thin film provided so as to cover the electrode body surface 101a. The outer surface of the adhesion prevention film 101B constitutes the electrode surface 101b of the electrode portion 101.
On the side portion of the electrode surface 101b excluding the blade portion 101c, an abdominal portion 101d formed in a loosely curved or planar shape as a whole is formed. The abdomen 101d is mainly used to hold down the body to be treated and perform treatments such as coagulation and cauterization.

As the material of the electrode body 101A, an appropriate metal material having conductivity such as a metal or an alloy is used. For example, as the material of the electrode body 101A, an aluminum alloy, stainless steel, or the like may be used.

The adhesion-preventing film 101B has the same configuration as any of the adhesion-preventing films 2, 7, and 12 in the first to third embodiments. The electrode body 101A in this embodiment corresponds to the medical device surface portion 1 in the first to third embodiments.

Next, the operation of the high-frequency knife 100 having such a configuration will be described.
The treatment using the high frequency knife 100 is performed, for example, in a state where the return electrode 106 is attached to the patient and a high frequency voltage is applied to the electrode portion 101 by the high frequency power supply 103. The surgeon brings the blade portion 101c or the abdomen 101d of the electrode portion 101 into contact with the treated body such as the treated portion of the patient while the high frequency voltage is applied to the electrode portion 101.
The electrode portion 101 is covered with an adhesion prevention film 101B. Inside the adhesion prevention film 101B, first and second conductive particle groups are dispersed, and a part of them is exposed on the electrode surface 101b. Inside the adhesion prevention film 101B, the first and second conductive particles of the first and second conductive particle groups come into contact with each other, and a part of the first and second conductive particles come into contact with the electrode body surface 101a, thereby causing the adhesion prevention film 101a. Conductive paths continuous in the thickness direction of 101B are formed.
The electrode surface 101b of the adhesion prevention film 101B is formed with an uneven shape by exposing the first and second conductive particles exposed from the silicone 4 to which the biological tissue is hard to adhere.

When a high frequency voltage is applied between the electrode portion 101 and the counter electrode plate 106, a high frequency current is generated through the adhesion prevention film 101B. At the contact portion between the electrode portion 101 and the living tissue, a current having a high current density flows from the first and second conductive particles exposed on the electrode surface 101b to the living tissue, and Joule heat is generated. As a result, the water content of the biological tissue of the treated body rapidly evaporates, and the biological tissue is broken at the blade portion 101c. Therefore, the electrode portion 101 is moved with respect to the living tissue, so that the living tissue can be incised and excised.
When a high-frequency current is applied while the abdomen 101d is pressed against the treated body, the water content of the living tissue of the treated body rapidly evaporates, and the living tissue is coagulated in the vicinity of the abdomen 101d. Therefore, when the abdomen 101d is pressed against the body to be treated, hemostasis and cauterization of living tissue become possible.
When the necessary treatment is completed, the operator separates the electrode portion 101 from the treated body. At this time, since the electrode surface 101b in contact with the biological tissue is formed by the adhesion prevention film 101B, the biological tissue is easily peeled from the electrode surface 101b when the electrode portion 101 is separated.
As a result, in the high frequency knife 100, the biological tissue hardly adheres to the electrode surface 101b. Therefore, according to the high frequency knife 100, it is possible to prevent deterioration of the treatment performance during the treatment. Further, the durability of the electrode portion 101 is ensured even if the electrode portion 101 is used repeatedly.

As described above, according to the high-frequency knife 100, since the adhesion prevention film 101B is provided on the surface of the electrode portion 101, the adhesion prevention performance of biological substances can be improved.

In the description of each of the above embodiments, an example in which the outermost layer is composed of the first conductive particle group and the second conductive particle group has been described. However, the plurality of conductive particle groups is not limited to two groups, and may be three or more groups.
Only one conductive particle group may be used as long as the required uneven shape and conductivity can be obtained according to the purpose of use of the medical device in which the adhesion prevention film for medical devices is used.

In the description of the second embodiment, the case where the first layer 6 is composed of a silica layer containing silica as a main component has been described, but the material of the first layer 6 is the medical device surface portion 1 and the second layer. An appropriate material can be used depending on the material of No. 3, and the material is not limited to the silica layer.

In the description of the second embodiment, the case where the adhesion prevention film 7 is a multilayer film having a two-layer structure has been described. However, the adhesion prevention film for medical devices may be a multilayer film having three or more layers. In this case, since an intermediate layer can be provided between the lowermost layer and the outermost layer, it is appropriate even when there is no material having good adhesion to both the base material and the outermost layer of the grip portion of the medical device. By sandwiching the intermediate layer, stronger fixing becomes possible.
Further, the materials of the first layer 6 and the intermediate layer are not limited to the materials having a uniform component. For example, it may be composed of an inclined layer in which the composition ratio of the components changes in the layer thickness direction.

In the description of the third embodiment, of the plurality of conductive particle groups, only the first conductive particle group has a particulate base material made of a non-conductor and a metal layer laminated on the surface of the base material. The case where composite particles having and are included has been described. However, in the third embodiment, the composite particles may be contained only in the second conductive particle group, or the composite particles may be contained in the first and second conductive particle groups.
When the adhesion prevention film for medical devices contains three or more conductive particle groups, at least one of the three or more conductive particle groups may contain composite particles. In this case, in order to efficiently reduce the component cost and improve the heat insulating property, the composite particles may be contained only in the conductive particle group having the largest median diameter.

Next, examples of the adhesion prevention film for medical devices according to the first to third embodiments described above will be described together with comparative examples.
First, Examples 1 to 5 of the adhesion prevention film 2 of the first embodiment and Example 6 of the adhesion prevention film 7 of the second embodiment will be described together with Comparative Examples 1 and 2.
The following [Table 1] and [Table 2] show the composition of the outermost layer-forming paint that forms the adhesion-preventing film for medical devices of each Example and each Comparative Example, and the evaluation results. However, in [Table 1], the notation of the code of each member is omitted.

[Example 1]
Example 1 is an example of the adhesion prevention film 2. The adhesion prevention film 2 of Example 1 was manufactured as follows.
An aluminum substrate was used as the substrate for forming the adhesion prevention film 2.
An outermost layer in which 10 parts by weight of silicone resin, 30 parts by weight of first conductive particles, 30 parts by weight of second conductive particles, and 30 parts by weight of solvent are mixed to form the adhesion prevention film 2. A forming paint was prepared.
As the silicone resin, SILRES (registered trademark) MPF 52 E (trade name; manufactured by Asahi Kasei Wacker Silicone Co., Ltd.) was used. As the first conductive particle 5A, gold particles having a median diameter of 5 μm were used. As the second conductive particle 5B, gold particles having a median diameter of 50 nm were used. Here, as a means for measuring the particle size distribution, a microtrack particle size analyzer using a laser diffraction / scattering method is used for measuring the first conductive particles, and a dynamic light scattering method is used for measuring the second conductive particles. A nanotrack particle size analyzer was used. Xylene was used as the solvent.
The coating material for forming the outermost layer was coated on an aluminum substrate by a dip coat and dried at a temperature of 200 ° C. for 1 hour. As a result, an adhesion prevention film 2 having a film thickness of 5.0 μm was formed.
The maximum height Rz of the surface 2a of the adhesion prevention film 2 was measured with a laser microscope OLS-3500 (trade name: manufactured by Olympus Corporation) and found to be 3.5 μm.

[Examples 2 to 5]
In Examples 2 to 5, as shown in [Table 1], except that at least one of the first conductive particles 5A and the second conductive particles 5B has a median diameter different from that of the first embodiment. It was configured in the same manner as in Example 1.
In Examples 2 to 4, the median diameter of the second conductive particle 5B was 50 nm, and the median diameter of the first conductive particle 5A was 1 μm, 5 μm, and 20 μm, respectively.
Example 5 was configured in the same manner as in Example 1 above, except that the median diameter of the second conductive particle 5B was set to 500 nm.
When the maximum height Rz of the surface 2a of the adhesion prevention film 2 of Examples 2 to 5 was measured in the same manner as in Example 1, they were 0.7 μm, 3.0 μm, 15.1 μm, and 3.3 μm, respectively. It was.

[Example 6]
Example 6 is an example of the adhesion prevention film 7, and the first layer 6 is provided with a silica layer, and the second layer 3 is configured in the same manner as the adhesion prevention film 2 of the above-mentioned Example 3.
The adhesion prevention film 7 of Example 6 was manufactured as follows.
First, Olam (registered trademark) 60 (trade name; manufactured by Artbreed Co., Ltd.) was applied to the surface of an aluminum substrate similar to that in Example 1 by spin coating, and then dried at 200 ° C. for 1 hour. As a result, a silica layer having a layer thickness of 1.0 μm was formed. Then, the outermost layer forming paint for forming the second layer 3 was coated on the silica layer in the same manner as in Example 1 above, and dried at a temperature of 200 ° C. for 1 hour. As a result, the second layer 3 having a layer thickness of about 4.6 μm was formed.
The maximum height Rz of the surface 2a of the adhesion prevention film 7 of Example 6 was measured in the same manner as in Example 1 and found to be 3.6 μm.

[Comparative Examples 1 and 2]
As shown in [Table 1], the adhesion prevention film for medical devices of Comparative Example 1 includes 60 parts by weight of gold particles having a median diameter of 10 μm in place of the first conductive particles 5A in Example 1 above. , The second conductive particle 5B was deleted.
In the first embodiment, the anti-adhesion film for medical devices of Comparative Example 2 includes 60 parts by weight of gold particles having a median diameter of 50 nm instead of the second conductive particles 5B, and the first conductive particles 5A are provided. It was deleted and configured.
When the maximum height Rz of the surface 2a of the adhesion prevention film for medical devices of Comparative Examples 1 and 2 was measured in the same manner as in Example 1, they were 7.5 μm and 0.2 μm, respectively.

[Evaluation method]
Adhesion evaluation and conductivity evaluation were performed using the adhesion prevention films for medical devices of Examples 1 to 6 and Comparative Examples 1 and 2 as test samples. [Table 2] shows the evaluation results of the adhesiveness evaluation and the conductivity evaluation.

As an evaluation of adhesion, a test sample is heated at 200 ° C. on a hot plate, horse blood is poured onto it as a biological substance, and then a tape peeling test by a cross-cut method based on JIS K5600-5-6 is performed. It was implemented.
In the adhesion evaluation, the peeled state of the solidified horse blood in the test sample after the test was evaluated based on the classification in Table 1 described in JIS K5600-5-6. When the peeled state corresponds to "Category 5", it was evaluated as no adhesion (described as "good" in [Table 2]). When the peeling state was "Category 0 to 4", it was evaluated as having adhesion (described as x (no good) in [Table 1]).
In each of the test samples of Examples 1 to 6 and Comparative Examples 1 and 2, a part or all of the adhesion prevention membrane for medical devices was not peeled off together with the solidified horse blood.

As the conductivity evaluation, the volume resistivity of the test sample was measured.
When the volume resistivity is not more than 1.0 × 10 ⁸ Ω · cm, the conductive good (described as [Table 1] ○ (good)), the volume resistivity of 1.0 × 10 ⁸ Ω · cm When it exceeded, the conductivity was evaluated as poor (described as × (no good) in [Table 2]).

[Evaluation results]
According to the evaluation results of the adhesion evaluation shown in [Table 2], in the adhesion prevention films for medical devices of Examples 1 to 6 and Comparative Example 1, even if the horse blood denatured in the heated state adheres, the tape is taped. After the peeling test, it was evaluated as "no adhesion". Therefore, it can be seen that the performance of preventing the adhesion of biological substances is good.
On the other hand, in Comparative Example 2 which does not contain the first conductive particle 5A, it is evaluated as “with adhesion”, and it can be seen that the performance of preventing the adhesion of biological substances is inferior.
Since the surface material of the adhesion prevention film for medical devices of each test sample is the same, these differences are due to the difference in the uneven shape of the surface formed by the first conductive particles and the second conductive particles. to cause.
In Examples 1 to 6 and Comparative Example 1, since the first conductive particles 5A having a median diameter of 1 μm to 20 μm are contained, the uneven shape of the surface of the adhesion prevention film for medical devices is as described above. The maximum height Rz was 0.7 μm to 15.1 μm.
On the other hand, since the median diameter of the second conductive particle 5B in Comparative Example 2 is 50 nm, the surface unevenness of the adhesion prevention film for medical devices is simply exposed to the surface of the second conductive particle 5B. The maximum height Rz of the shape was 0.2 μm. As described above, it is considered that the adhesion prevention film of Comparative Example 2 has a smooth surface close to a flat surface, so that the adhesion with the biological substance is strengthened.

According to the evaluation results of the conductivity evaluation shown in [Table 2], the adhesion prevention films for medical devices of Examples 1 to 6 and Comparative Example 2 had good conductivity.
On the other hand, in Comparative Example 1 which does not contain the second conductive particle 5B, the conductivity was poor.
In Examples 1 to 6 in which the first conductive particles 5A and the second conductive particles 5B coexist, the first conductive particles 5A come into contact with each other, and the first conductive particles 5A or the first conductive particles 5A or the first. The second conductive particle 5B having a small diameter also enters the gap between the conductive particle 5A and the aluminum substrate. Therefore, it is considered that the conductivity is improved by filling these gaps with the second conductive particles 5B.
In Comparative Example 1, since the second conductive particles 5B are not included, the first conductive particles 5A are electrically connected to each other or only at the contact point between the first conductive particles 5A and the aluminum substrate. As a result, since the substantial contact area is smaller than that of Examples 1 to 6 and Comparative Example 2, it is considered that the electric resistance is increased.

Next, Examples 7 and 8 of the adhesion prevention film 12 of the third embodiment and Examples 9 and 10 of the adhesion prevention film combining the second and third embodiments will be described.
The following [Table 3] shows the blending composition of the outermost layer forming paint for forming the adhesion prevention film for medical devices of Examples 7 to 10. However, in [Table 3], the notation of the code of each member is omitted.

[Examples 7 and 8]
Examples 7 and 8 are examples of the adhesion prevention film 12.
Example 7 was configured in the same manner as in Example 1 except that the first conductive particles 15A were used instead of the first conductive particles of Example 1.
Hollow silica and gold were used for the base material 15a and the metal layer 15b of the first conductive particles 15A in this example, respectively. The layer thickness of the metal layer 15b was set to 0.5 μm. The median diameter of the first conductive particle 15A in this example was 20 μm.
Example 8 has the same configuration as that of Example 7, except that the material and median diameter of the second conductive particle 5B are changed and the material of the first conductive particle 15A is changed. Was done.
The material of the second conductive particle 5B in this embodiment is made of platinum. The median diameter of the second conductive particle 5B of this example was 500 nm.
When the maximum height Rz of the surface 12a of the adhesion prevention film 12 in Examples 7 and 8 was measured in the same manner as in Example 1, they were 16.5 μm and 14.1 μm, respectively.

[Examples 9 and 10]
Examples 9 and 10 include a first layer 6 similar to that of the sixth embodiment.
Example 9 has the same configuration as the adhesion prevention film 12 of Example 8 except that the material and median diameter of the first conductive particles 15A are changed instead of the second layer 3 of Example 6. It is provided with a layered film of. Zirconia and platinum were used for the base material 15a and the metal layer 15b of the first conductive particles 15A in this example, respectively. The layer thickness of the metal layer 15b was set to 0.05 μm. The median diameter of the first conductive particle 15A in this example was 1 μm.
Example 10 has the same configuration as the adhesion prevention film 12 of Example 7 except that the material and median diameter of the first conductive particles 15A are changed instead of the second layer 3 of Example 6. It is provided with a layered film of. Alumina and gold were used for the base material 15a and the metal layer 15b of the first conductive particles 15A in this example, respectively. The layer thickness of the metal layer 15b was 0.03 μm. The median diameter of the first conductive particle 15A in this example was 1 μm.
When the maximum height Rz of the surface of the outermost layer in Examples 9 and 10 was measured in the same manner as in Example 1, it was 0.31 μm and 0.53 μm, respectively.

[Evaluation results]
Using Examples 7 to 10, the same adhesion evaluation and conductivity evaluation as in Examples 1 to 6 were performed. The evaluation results are shown in [Table 4] below. The meanings of the symbols indicating the evaluation results of "adhesiveness" and "conductiveness" in [Table 4] are the same as the meanings of the symbols in [Table 2].

As shown in [Table 4], in each of the examples, the adhesion evaluation was "no adhesion"("○" in [Table 4]), and the conductivity evaluation was "good"("Table4]". ○ ”).
Therefore, it can be seen that even when the first conductive particles 15A have conductivity only on the surface layer due to the metal layer 15b, good conductivity is obtained by combining with the second conductive particles 5B. ..

[Insulation evaluation]
Next, the evaluation of heat insulating properties in the film configuration of each embodiment will be described.
In order to evaluate the heat insulating property of each example, a test sample for evaluating the heat insulating property was prepared. In the test sample for evaluating the heat insulating property, the adhesion prevention film of each of the above-described examples was formed on the surface of an aluminum plate having a plate thickness of 3 mm. However, in order to accurately measure the difference in heat insulating property, the film thickness of the test sample for evaluating heat insulating property was set to 25 μm ± 5 μm.
Each test sample was placed on a hot plate heated to 200 ° C. so that the aluminum plate was in contact with the hot plate. Each test sample was heated for at least 1 minute. The temperature of the film surface 1 minute after the start of heating was measured by a microsurface thermometer. The temperature after 1 minute is shown in [Table 5] below.

The aluminum plate used for the test sample had a surface temperature of 200 ° C. on the opposite side of the hot plate after heating for 1 minute. Therefore, when the temperature after 1 minute of the test sample is less than 200 ° C., it can be said that the heat insulating effect of the adhesion prevention film appears.

As an evaluation of heat insulating property, when the temperature 1 minute after the test sample is 20 ° C. or more lower than the equilibrium temperature (200 ° C.) of the aluminum plate, the heat insulating property is evaluated as "very good" (◎ (very good)). Was done. When the temperature after 1 minute of the test sample was lower than the equilibrium temperature of the aluminum plate by 5 ° C. or higher and lower than 20 ° C., the heat insulating property was evaluated as “good” (good). When the temperature after 1 minute of the test sample was 0 ° C. or higher and lower than 5 ° C. below the equilibrium temperature of the aluminum plate, the heat insulating property was evaluated as “poor” (x (no good)).

[Insulation evaluation result]
As shown in [Table 5], the temperatures after 1 minute of Examples 1 to 6 were 188 ° C, 192 ° C, 188 ° C, 191 ° C, 192 ° C, and 190 ° C, respectively. The heat insulating properties of Examples 1 to 6 were judged to be "good" (described as "◯" in [Table 5]).
The temperatures after 1 minute of Examples 7 to 10 were 170 ° C., 178 ° C., 176 ° C., and 180 ° C., respectively. The heat insulating property of Examples 7 to 10 was determined to be "very good" (described as "⊚" in [Table 5]).
In Examples 7 to 10, the first conductive particles 15A are formed by laminating a thin metal layer 15b on a non-conductive base material 15a, which has poor thermal conductivity as compared with a metal material. Therefore, it is considered that Examples 7 to 10 have very good heat insulating properties. Even the temperature after 1 minute of Example 10, which had the worst heat insulating property in Examples 7 to 10, was 8 higher than the temperature after 1 minute of Examples 1 and 3, which had the highest heat insulating property in Examples 1 to 6. The temperature was also low.
In particular, in Example 7, the temperature was 30 ° C. lower than the equilibrium temperature of the aluminum plate. It is considered that the reason for this is that since hollow silica is used as the base material 15a, the heat insulating effect due to the hollow structure is added.

Although each preferred embodiment of the present invention has been described above together with each embodiment, the present invention is not limited to each of these embodiments and examples. Configurations can be added, omitted, replaced, and other modifications without departing from the spirit of the present invention.
Further, the present invention is not limited by the above description, but is limited only by the appended claims.

1 Medical device surface 1a Surfaces 2, 12 Adhesion prevention film (adhesion prevention film for medical devices, outermost layer)
2a, 12a surface (outermost layer surface)
3 Second layer (outermost layer)
4 Silicone 5A, 15A First conductive particles 5B Second conductive particles 6 First layer (bottom layer)
7,101B Adhesion prevention film (adhesion prevention film for medical devices)
15a Base material 15b Metal layer 100 High frequency knife (medical equipment)
101 Electrode part 101a Electrode body surface 101A Electrode body 101b Electrode surface

Claims (9)

A single-layer or multi-layered anti-adhesion film formed on the surface of a medical device that emits high-frequency power to a biological substance .
It is provided with an outermost layer having a resin having a continuous use temperature of 200 ° C. or higher and a plurality of conductive particles.
Concavities and convexities are formed on the surface of the outermost layer by exposing a part of the plurality of conductive particles from the resin .
The plurality of conductive particles are
The first conductive particle group having a median diameter of 1 μm or more and 20 μm or less,
A second group of conductive particles having a median diameter of 0.01 μm or more and 0.5 μm or less,
Including ,
Adhesion prevention film for medical devices. The resin having a continuous use temperature of 200 ° C. or higher
Includes one or more resins selected from the group consisting of silicone resins, furan resins, polyamide resins, allyl resins, polyimide resins, PEEK resins, epoxy resins.
The adhesion-preventing film for medical devices according to claim 1. The resin having a continuous use temperature of 200 ° C. or higher
Silicone resin,
The adhesion-preventing film for medical devices according to claim 1. The size of the unevenness on the surface of the outermost layer is
The maximum height Rz is 0.3 μm or more.
The adhesion-preventing film for medical devices according to any one of claims 1 to 3 . The first conductive particle group is
A composite particle having a particulate base material made of a non-conductor and a metal layer laminated on the surface of the base material.
The adhesion-preventing film for medical devices according to any one of claims 1 to 4 . The plurality of conductive particles are
A composite particle having a particulate base material made of a non-conductor and a metal layer laminated on the surface of the base material.
The adhesion-preventing film for medical devices according to any one of claims 1 to 4 . The plurality of conductive particles are
Containing one or more metals selected from the group consisting of silver, platinum, copper, nickel, and gold,
The adhesion-preventing film for medical devices according to any one of claims 1 to 6 . A lowermost layer containing silica as a main component and in close contact with the surface of the medical device is provided on the lower layer side of the outermost layer.
The adhesion-preventing film for medical devices according to any one of claims 1 to 7 . A medical device that emits high-frequency power to biological substances.
A medical device comprising the adhesion-preventing film for a medical device according to any one of claims 1 to 8 .

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